Principal Operations Quality Engineer (Medical Devices)

Location: North Haven, Connecticut, United States; onsite five days per week. Minimal travel is expected.

Salary: $120,800–$181,200 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Lead quality standards, procedures, protocols, and quality-system improvements supporting manufacturing operations and surgical stapling products.
• Partner with Engineering and Manufacturing to integrate quality requirements into products, processes, and operational controls.
• Develop and oversee inspection, testing, evaluation, and equipment-accuracy methods.
• Lead root-cause investigations, statistical analyses, risk assessments, corrective actions, and preventive actions.
• Maintain compliant quality documentation and records in accordance with internal procedures, regulatory requirements, and applicable standards.
• Provide technical leadership, mentoring, and direction during strategic projects, audits, escalations, and significant manufacturing events.

Requirements

• Bachelor’s degree with 7+ years of relevant experience, or master’s degree with 5+ years, or PhD with 3+ years.
• Experience supporting quality engineering activities in a regulated manufacturing environment.
• Advanced knowledge of FDA Quality System requirements, ISO 13485, risk management, CAPA, nonconforming product controls, change control, and process validation.
• Experience with complex investigations, product and process nonconformances, systemic quality issues, root-cause analysis, statistical methods, and risk assessment.
• Strong manufacturing-floor experience and the ability to make technically sound, audit-defensible quality decisions.
• U.S. work authorization sponsorship is available for Principal-level roles and above; the role requires onsite work in North Haven, Connecticut.

Nice to have

• ASQ Certified Quality Engineer, Certified Quality Auditor, Six Sigma Black Belt, Shainen RedX, or similar certification.
• Experience mentoring engineers or leading technical project teams in a matrixed organization.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and long-term disability coverage.
• Paid time off, paid holidays, short-term disability, and employee assistance programs.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.